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FDAClass II

Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL… Recalled: Presence of Particulate Matter: Hair was found in product

Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per… was recalled on July 16, 2026 in cooperation with the U.S. Food and Drug Administration because presence of Particulate Matter: Hair was found in product.

Is my unit affected?

Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07

Model, lot & date codes to check

Lot #: 6134349, 6134620 Exp. Date 11/2026

Units affected: 59,425 vials

Where it was sold: Nationwide within in the USA

Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.

What's the hazard?

Presence of Particulate Matter: Hair was found in product

Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.

Your remedy & how to claim it

Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.

Contact: Recalling firm: Fresenius Kabi USA, LLC

Not sure what you're entitled to? Read our guide: what to do if your product is recalled.

Official recall notice

Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.

View official notice →

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